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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904515460
Recall Number D-477-2014
Classification Class II
Code Info GUAIFENESIN, Tablet, 200 mg has the following code Pedigree: W002853, EXP: 6/7/2014.
Product Distributed Qty 100 Tablets
Reason For Recall Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W002850, EXP: 6/7/2014.

Event Detail

Event Id 65707
Product Type Drugs
Status Ongoing
Recalling Firm Aidapak Services, LLC
City Vancouver
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-02
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Repacked drugs were distributed in Arizona, California, Oregon, and Washington.